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NauseaPhase 1NCT06342778

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers

A Phase 1 study testing Doxylamine + Pyridoxine and Diclectin in people with Nausea, run by Valenta Pharm JSC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate pharmacokinetic profile and establish bioequivalence of the investigational drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia) compared to the reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration… Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Nausea
What is being tested?
Doxylamine + Pyridoxine and Diclectin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteRussia
Study dates
27 Feb 2024to 2 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntary and personally signed informed consent form by the heathy subject prior to initiation of any study procedures.
  • Women of childbearing potential (18 to 49 years inclusive).
  • Verified "healthy" status with no abnormalities detected based on clinical, laboratory, and instrumental examinations specified in the study protocol.
  • Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 139 mmHg, diastolic blood pressure (DBP) from 60 to 89 mmHg (inclusive).
  • Heart rate (HR) from 60 to 90 beats per min (inclusive).
  • Respiratory rate (RR) 12 to 18 breaths per min (inclusive).
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  • Body temperature from 36 to 36.9°C (inclusive).
  • Body mass index (BMI) of 18.5 ≤ BMI ≤ 30 kg/m², with body weight ≥ 45 kg.
  • Consent to use adequate contraceptive methods throughout the study and for 30 days after completion of the study, negative pregnancy test.
  • Volunteers must demonstrate appropriate behavior and coherent speech.
  • Non-inclusion Criteria:
  • Positive allergic history.
  • History of hypersensitivity to the active ingridient and/or excipients of the study drugs.
  • A history of drug intolerance to the active ingridient and/or excipients of the study medications.
  • Chronic diseases of cardiovascular, lymphatic, respiratory, nervous, endocrine, digestive, musculoskeletal, integumentary, immune systems, as well as genitourinary apparatus and hematopoietic organs.
  • Clinically significant deviations from normal reference values for laboratory and diadnostic parameters based on local laboratory standarts.
  • History of gastrointestinal tract surgery (excluding appendectomy performed at least 1 year prior to screening).
  • Diseases/conditions that, in the investigator's judgement, may affect the absorption, distribution, metabolism, or excretion of study drugs.
  • Acute infectious diseases within 4 weeks prior to screening.
  • Use of medications with significant effects on hemodynamics or those affecting liver fuction (barbiturates, benzodiazepines, omeprazole, cimetidine, etc.) within 1 month prior to screening.
  • Regular use of medicatins within 3 weeks prir to screening or single-dose medication intake within 7 days prior to screening.
  • Blood or plasma donation within 3 months prior to the Screening Visit.
  • Use of hormonal contraceptives within 2 months prior to the Screening Visit.
  • Use of depot injections of any medications within 3 months prior to the Screening Visit.
  • Pregnancy or lactation period, positive pregnancy test.
  • Participation in another clinical trial less than 3 months prior to screening or concurrently with the present study.
  • Consumption of more than 10 units of alcohol (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits) per week in the last month prior to inclusion in the study or history of alcoholism, drug abuse, or medicines abuse.
  • Smoking.
  • Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens, rapid test (nasopharyngeal and/or oropharyngeal swab) for SARS-Cov-2 (COVID-19).
  • Clinically significant abnormalities on electrocardiogram (ECG).
  • Positive urinalysis for narcotics and potent drugs.
  • Positive breath alcohol vapor test.
  • Scheduling a hospital stay during the study period, for any reason other than hospitalization required by this protocol.
  • Inability or inability to comply with the requirements of the protocol, to follow the procedures prescribed by the protocol, to follow the diet, activity regime.
  • Observance of religious fasting or special diet (e.g., vegetarian, vegan).
  • Other conditions that, in the Investigator's judgement, may interfere with the volunteer's participation in the study or lead to early withdrawal, including lifestyle factors such as night shift work or extreme physical exertion.

Who cannot join

  • Refusal by the volunteer to continue participation in the study.
  • Failure of the volunteer to comply with study protocol requirements, including missed visits, unauthorized use of prohibited medications, or non-adherence to dietary and lifestyle restrictions.
  • Occurrence of safety-related issues during the study that endanger the subject (e.g. hypersensitivity reactions, etc.).
  • Volunteers included in the study in violation of the inclusion/non-inclusion criteria.
  • Volunteer developing a severe and/or serious adverse event during the study.
  • Missing collection of 2 or more consecutive blood samples, or 3 or more blood samples within a single period of pharmacokinetic part of the study.
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  • Occurrence of vomiting/diarrhea within 24 h after administration of the study drug (the choice of time interval is based on the value of tmax parameter for doxylamine and pyridoxal-5-phosphate, not exceeding 7.2 ± 1.9 and 11.7 ± 5.3 h, respectively, according to the manufacturer of the reference drug).
  • Positive urine test for narcotics and potent drugs.
  • Positive breath alcohol vapor test.
  • A positive pregnancy test.
  • A positive test for SARS-Cov-2 (COVID-19);
  • Development of any new condition or situation that hinders protocol-defined procedures.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • State budgetary health care institution Yaroslavl region "Clinical Hospital № 3"

    Yaroslavl, 150007

Other trials in Russia

About this study

Official title: An Open-label, Randomized, Crossover, Two-period Study of the Comparative Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine, 10 mg + 10 mg Enteric-soluble Film-coated Tablets (Valenta Pharm JSC, Russia) and Diclectin, 10 mg + 10 mg Delayed-release Tablets (Duchesnay Inc, Canada) Under Fed Conditions in Healthy Volunteers

This study aims to evaluate pharmacokinetic profile and establish bioequivalence of the investigational drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia) compared to the reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers under fed conditions.

Conditions
Nausea
Being tested
Doxylamine + Pyridoxine, Diclectin
Medical subject headings
Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxylamine + PyridoxineDrug

    Also called Doxylamine + Pyridoxine, enteric soluble film-coated tablets

    A single dose of R or T drug in each of 2 periods of the study under fed conditions

  • DiclectinDrug

    Also called Doxylamine + Pyridoxine, Delayed-release Tablets

    A single dose of R or T drug in each of 2 periods of the study under fed conditions

Study groups in NCT06342778
Study groupRoleWhat they receive
RT-sequenceExperimentalGroup 1 (14 volunteers, RT sequence) will take 2 tablets of Diclectin in Period 1 and 2 tablets of Doxylamine + Pyridoxine in Period 2
Receives: Drug: Doxylamine + Pyridoxine; Drug: Diclectin
TR-sequenceActive comparatorGroup 2 (14 volunteers, TR sequence) will take 2 tablets of Doxylamine + Pyridoxine in Period 1 and 2 tablets of Diclectin in Period 2
Receives: Drug: Doxylamine + Pyridoxine; Drug: Diclectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics - Cmax

    Maximum plasma concentration (Cmax) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  3. Pharmacokinetics - AUC0-t

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  4. Pharmacokinetics - AUC0-inf

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC of doxylamine and pyridoxal-5-phosphate, defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  7. Pharmacokinetics - kel

    Elimination constant (kel) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  8. Pharmacokinetics - MRT

    Mean residence time (MRT) of doxylamine and pyridoxal-5-phosphate

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  9. Bioequivalence - ratio of Cmax

    Ratio of geometric mean Cmax for doxylamine and pyridoxal-5-phosphate after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  10. Bioequivalence - ratio of AUC0-t

    Ratio of geometric mean AUC0-t for doxylamine and pyridoxal-5-phosphate after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

  11. Bioequivalence - ratio of AUC0-inf

    Ratio of geometric mean AUC0-inf for doxylamine and pyridoxal-5-phosphate after intake of R or T (with 90% confidence intervals)

    Measured: From 0 to 72 hours (Day 1-4 and Day 15-18)

Secondary outcomes (3)

  1. Adverse event type

    Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.

    Measured: From Day - 14 to Day 0 (screening) to Day 22 ± 1 (end of the study)

  2. Adverse event frequency

    Number and frequency of adverse events registered during the study

    Measured: From Day - 14 to Day 0 (screening) to Day 22 ± 1 (end of the study)

  3. Adverse event severety

    Severity of adverse events registered during the study

    Measured: From Day - 14 to Day 0 (screening) to Day 22 ± 1 (end of the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start27 Feb 2024
  3. Primary completion2 May 2024
  4. Study completion2 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342778
Sponsor's protocol ID
DIP-05-02-2023
Status last verified
Jul 2025
First submitted
11 Mar 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doxylamine + Pyridoxine and Diclectin in people with Nausea, run by Valenta Pharm JSC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics - Cmax (time frame: From 0 to 72 hours (Day 1-4 and Day 15-18)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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